System for anchoring medical devices

ABSTRACT

Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This is a continuation of U.S. patent application Ser. No. 13/233,946filed on Sep. 15, 2011, now issued as U.S. Pat. No. 8,936,576, theentire contents of which are incorporated herein by reference.

TECHNICAL FIELD

This document relates to an anchor device, such as a device for use insecuring the position of a catheter or another medical instrument.

BACKGROUND

Venous, arterial, and body fluid catheters are commonly used byphysicians. For example, such catheters may be used to gain access tothe vascular system for dialysis, for introducing pharmaceutical agents,for nutrition or fluids, for hemodynamic monitoring, and for blooddraws. Alternatively, catheters can be used for drainage of fluidcollections and to treat infection. Following introduction into thepatient, the catheter is secured to the patient. In conventionalpractice, the catheter is commonly secured to the patient using anadhesive tape on the skin or by suturing a catheter hub to the patient'sskin.

SUMMARY

Some embodiments of a medical device anchor system include an anchordevice that receives a medical instrument (such as a catheter or thelike) and secures the instrument in place relative to a skin penetrationpoint. In some circumstances, anchor device may be equipped with agripping channel that frictionally engages an outer surface of themedical instrument at a location external to skin penetration point. Thegripping channel can be shaped in a manner that provides a secureengagement with the medical instrument without necessarily overlycompressing the medical instrument. In particular embodiments, thegripping channel can have a cross-sectional shape that is different fromthe cross sectional shape of the portion of the medical instrument thatis engaged therewith. Moreover, the anchor device can be equipped withone or more subcutaneous anchor elements that are configured to abut anunderside of a skin layer when deployed in a subcutaneous region. Insome embodiments, the portion of each subcutaneous anchor element thatis configured to reside under the skin layer can have a generallylongitudinally straight shape and a dull or otherwise bulbous tip so asto anchor the remaining external portion of the anchor device in amanner that reduces the likelihood of damage to the tissue surroundingthe skin penetration point.

In some embodiments, an anchor device for securing the position of acatheter may include an external retainer assembly to releasably coupleto a catheter. The external retainer assembly may have a longitudinalaxis extending from a proximal end to a distal end. The anchor devicemay further include first and second anchors that extend distally fromthe distal end of the external retainer assembly. Each anchor maycomprise a flexible tine that is deployable in a subcutaneous region tosecure the external retainer assembly relative to a skin penetrationpoint. The external retainer assembly may define a gripping channelextending generally parallel to the longitudinal axis of the externalretainer assembly so as to engage an exterior surface of to the catheterwhen the external retainer assembly releasably couples to the catheter.The gripping channel may have a non-circular cross-sectional shape in aplane generally perpendicular to the longitudinal axis.

In further embodiments, an anchor device for securing the position of acatheter may include an external retainer assembly to releasably coupleto a catheter. The external retainer assembling may have a longitudinalaxis extending from a proximal end to a distal end. The anchor devicemay further include first and second anchors that extend distally fromthe distal end of the retainer body. Each anchor may comprise a flexibletine that is deployable in a subcutaneous region to secure the externalretainer assembly relative to a skin penetration point. Each flexibletine may extend substantially straight to a respective free end having arounded tine tip. The external retainer assembly may define a channelextending along the longitudinal axis of the external retainer assemblyto frictionally engage an exterior surface of to the catheter when theexternal retainer assembly releasably couples to the catheter.

Some embodiments include a method of using an anchor device. The methodmay include advancing a catheter though a skin penetration point. Themethod may include directing an anchor device toward the skinpenetration point that is occupied by a portion of the catheter. Theanchor device may comprise an external retainer assembly defining achannel to releasably couple to an exterior surface of the catheterarranged outside the skin penetration point, and the anchor device mayalso comprise first and second anchors extending distally from a distalend of the external retainer assembly. The channel may have across-sectional shape that is different than a cross sectional shape ofthe catheter. The method may further include inserting the first andsecond anchors through the skin penetration point that is occupied bythe catheter so that at least a portion of the first and second anchorsare deployed in a subcutaneous region proximate the skin penetrationpoint. The method may also include securing the catheter with theexternal retainer assembly so that the catheter is anchored relative tothe skin penetration point. The method may include pivoting the firstand second anchors about a longitudinal fold line defined by a portionof the external retainer assembly so that the first and second anchorsare adjusted from a deployed configuration to a removal configuration.Also, the method may include removing the first and second anchors fromthe subcutaneous region and the skin penetration point.

These and other embodiments may provide one or more of the followingadvantages. First, some embodiments of an anchor device may be equippedwith a gripping channel that frictionally engages an outer surface ofthe medical instrument at a location external to skin penetration point.The gripping channel can be shaped to releasably retain the medicalinstrument, such as a catheter, even if the outer surface of the medicalinstrument has a tapered shape. Moreover, the gripping channel can beshaped in a manner that provides a secure engagement with the medicalinstrument without necessarily overly compressing the medicalinstrument. In particular embodiments, the gripping channel can have across-sectional shape that is different from the cross sectional shapeof the portion of the medical instrument that is engaged therewith.

Second, the anchor device can include one or more subcutaneous anchorelements configured to deploy in a subcutaneous region under the skinproximate to the skin penetration point of the medical instrument. Thedistal portion of each subcutaneous anchor element that is configured toreside under the skin layer can have a generally longitudinally straightshape and a dull or otherwise bulbous tip so as to anchor the remainingexternal portion of the anchor device in a manner that reduces thelikelihood of damage to the tissue surrounding the skin penetrationpoint. Moreover, the anchor system can be used to releasably retain amedical instrument in a desired position relative to a skin penetrationpoint without necessarily requiring sutures or skin adhesives.

Third, in some embodiments, an anchor device can include a retentionportion that readily mates with a medical instrument (such as acatheter) and at least one subcutaneous anchor element extendingdistally from a distal-most end the retention portion to engage the skinpenetration point as the medical instrument. As such, the anchor devicemay be deployed so that subcutaneous anchor elements are insertedthrough the skin penetration point that is already occupied by themedical instrument. Such a configuration may allow the anchor device tobe used after medical instrument is already in place without the needfor a second penetration point for the anchor device.

Fourth, some embodiments of the anchor device can be equipped withstructures that promote convenient use for a medical practitioner orother user. For example, the retention member can include a capalignment feature the reduces the likelihood of improper alignment of acap member. In addition, the retention member can be equipped withremoval tabs that facilitate simplified removal of the cap member evenwhen the user is wearing surgical gloves.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an anchor device with a portion of thedevice located in a subcutaneous region, in accordance with someembodiments.

FIG. 2 is a top exploded view of the anchor device of FIG. 1 with themedical device retention portion in an open and deployed configuration.

FIG. 3 is a front exploded view of the anchor device of FIG. 1 with themedical device retention portion in an open and deployed configuration

FIGS. 4A-4B are front and rear views, respectively, of the anchor deviceof FIG. 1 with the medical device retention portion in a closed anddeployed configuration.

FIG. 5 is an exploded perspective view of the anchor device of FIG. 1.

FIG. 6 depicts a perspective view of the anchor device with the anchordevice in a folded configuration to facilitate insertion or removal.

FIG. 7 depicts a perspective view of a method of using an anchor system.

FIG. 8 depicts a perspective view of an anchor device with locating tabsfor securing a catheter (not shown).

FIG. 9 depicts an exploded perspective view of an anchor device with acap alignment feature.

FIG. 10 depicts a top view of an anchor device tabs to assist in removalof the cap of the anchor device.

FIG. 11 depicts a side view of the anchor device of FIG. 10.

FIG. 12 depicts a perspective view of an anchor device cap removalfeatures.

FIG. 13 depicts a front view of the anchor device of FIG. 12.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, some embodiments of a medical device anchor system10 include an anchor device 100 that releasably retains a medicalinstrument 20 (e.g., depicted as a catheter in this embodiment) in anoperative position relative to a portion of skin 30 (e.g., relative to askin penetration point 32). The anchor device 100 may include a base 110and a cap assembly 130. The base 110 may include a retainer body 111 andone or more anchors 140 a-b that extend distally from the retainer body111 for deployment in a subcutaneous layer 34. The base 110 can receivethe medical instrument 20, and the cap assembly 130 can be removablycoupled to the base 110 to secure the medical instrument 20 in agenerally fixed position relative to the base 110. As described ingreater detail below in connection with FIGS. 2-3, the base 110 and thecap assembly 130 can include gripping members 120 and 135, respectively,that at least partially define a gripping channel 122. When the capassembly 130 is coupled to the base 110, the gripping members 120 and135 can releasably engage with an outer surface of the medicalinstrument 20. The gripping channel 122 can be shaped in a manner thatprovides a secure engagement with the medical instrument 200 withoutnecessarily overly compressing the medical instrument 20. In someembodiments, the cross-sectional shape is non-circular in a planegenerally orthogonal to the longitudinal axis of the channel 122. Forexample, the gripping channel 122 can have a cross-sectional shape(e.g., a generally diamond-shaped cross-section in the depictedembodiment) that is different from the cross-sectional shape of theportion of the medical instrument (e.g., a generally cylindricalcross-sectional shape in this embodiment). In alternative embodiments,the non-circular cross-sectional shape of the channel 122 may begenerally polygonal, such as triangular, square, rectangular,pentagonal, hexagonal, or the like, or may be oblong and otherwisedifferent from the cross-sectional shape of the portion of the medicalinstrument to be engaged. The medical instrument 20 can extend from thegripping members 120 and 135 and through a penetration point 32 in apatient's skin 30 (e.g., through a small incision, a puncture, or thelike), while the retainer body 111 and the gripping members 120 and 135remain outside of the skin 30. In some embodiments, at least a portionof the gripping channel 122 is tapered. For example, the proximal end ofthe gripping channel 122 is shown to be tapered in FIG. 2, so that theopenings on each end of the gripping channel 122 are differently size,as further described below with reference to FIGS. 4A-B.

As described in more detail below, the anchor device 100 can secure thecatheter 20 in the operative position relative to the penetration point32 without necessarily requiring sutures or adhesive tapes bonded to theskin. For example, the base 110 can include the one or more anchors 140a and 140 b that extend distally from a distal end of the retainer body111 so as to penetrate through the same skin opening as the medicalinstrument 20. The anchors 140 a and 140 b can include anchor elements145 a and 145 b that, after insertion, reside in the subcutaneous region34 (e.g., a region under the dermal layers of the skin 30 that maycomprise a fatty tissue layer) so as to secure the position of theanchor device 100—and the medical instrument 20 retainedtherein—relative to the penetration point 32. In this embodiment, theanchor elements 145 a and 145 b are provided as subcutaneous tines thathave a generally longitudinally straight shape and a dull or otherwisebulbous tip, a shape that can provide benefits both during manufactureand during use.

Referring now to FIGS. 1-3, in some embodiments, the medical instrument20 can include a catheter to be inserted through the penetration point32 of the skin 30 as part of a medical procedure. For example, in theembodiment depicted in FIG. 1, a central venous catheter 20 can beinserted into a percutaneous opening surgically formed in the skin(e.g., penetration point 32), to the underside of the skin 30, and intoa vein 40 to provide vascular access for delivering medications orminimally invasive devices into a patient. After placement of thecatheter 20, the base 110 of the anchor device 100 can approach thepenetration point 32 such that the tips 142 of the anchors 140 a and 140b enter the skin 30 through the penetration point 32. As the anchordevice 100 is inserted through the penetration point 32, the tines 145 aand 145 b are stressed to flex against anchor shafts 141 a and 141 b(refer also to FIG. 10) so as to pass through the penetration point 32in a manner that reduces the likelihood of trauma to the surroundingskin tissue. As the anchors 140 a and 140 b are collectively advancedthrough the penetration point 32, the tines 145 a and 145 b are movedbeneath the dermal skin layers 36 of the skin 30. When the tines 145 aand 145 b reach the subcutaneous region 34, the tines 145 a and 145 bare biased to return toward an unstressed shape, as shown in FIG. 2,thereby deploying in the subcutaneous region 34.

Referring now to FIG. 2, the tines 145 a and 145 b extend substantiallystraight to respective free ends having rounded tine tips 146 thatreduce the likelihood of the tine tips 146 puncturing the underside ofthe dermal layers 36. When the tines 145 a and 145 b of the anchors 140a and 140 b are deployed in the subcutaneous region 34, the cap assembly130 can be removably coupled to the base 110 (refer to FIGS. 4A-4B),compressing the securing portions 120 and 135 of the anchor body 100causing the securing portions 120 and 135 to releasably engage with anouter surface of the medical instrument 20. In this way, the anchordevice 100 can be secured to the patient without the retainer body 111penetrating though the skin 30 of the patient and without necessarilyrequiring sutures or adhesive tapes bonded to the skin 30. In oneembodiment, tines 145 a and 145 b are substantially straight and extendgenerally perpendicular to the shafts 141 a and 141 b of the anchors 140a and 140 b. In other embodiments, tines 145 a and 145 b create an angleless than 90 degrees in relation to anchors 140 a and 140 b. Thisconfiguration may be preferred as it may reduce the likelihood of therounded tine tips 146 puncturing the underside of the dermal layers 36.Such a configuration may also be advantageous during the manufacturingprocess, permitting a high density of tines per square area to be formedon a single sheet of material. Having been manufactured from a sheet ofmaterial, the tines have cross-sections that are substantiallysquare-shaped.

Referring now to FIGS. 2-3 and 4A-4B, some embodiments of the anchordevice 100 can include structures designed to mate with portions of themedical instrument 20 to be retained by the anchor device 100. Theanchor device 100 can include the gripping members 120 and 135 used tosecure the catheter 20 (or other medical instrument) relative to theskin penetration point 32. For example, after the catheter 20 isdelivered into the targeted vein 40 (or other bodily lumen) and afterthe tines 145 a and 145 b are deployed in the subcutaneous region 34,the cap assembly 130 can be removably coupled to the base 110,compressing the gripping members 120 and 135 to temporarily engage withthe outer surface of the catheter 20. In this way, the anchor device 100can be transitioned from the open configuration (shown in FIGS. 2-3) tothe closed configuration (shown in FIGS. 4A-4B) to thereby secure thecatheter 20 with the gripping members 120 and 135. The gripping members120 and 135 may comprise a compliant material that provides a frictionalengagement with the outer circumferential surface of the catheter 20.For example, the gripping members 120 and 135 may comprise a lowdurometer thermoplastic elastomer (TPE). As described in more detailbelow, the retainer body 111 can include locking tabs 112 that can passthrough openings 132 in the cap 131 and positively engage at least aportion of perimeters 134 of the openings 132, thereby removablycoupling the cap assembly 130 to the base 110.

Still referring to FIGS. 2-3 and 4A-B, the anchor device 100 can includefeatures that facilitate separation from the catheter 20, which canpermit the catheter 20 and anchor device 100 to be removed from the skin30 independently of each other. For example, the tabs 112 may bedisengaged from the cap assembly 130 to decouple the cap assembly 130from the base 110. Once the cap assembly 130 is removed, the grippingmembers 120 and 135 can release from the catheter 20, thereby allowingthe catheter 20 to be moved relative to the anchor device 100. As such,the catheter 20 can be moved independently from the anchor device 100,for example, to withdraw the catheter 20 from the patient while at leasta portion of the anchor device 100 remains secured to the skin 30.

Some embodiments of the anchor device 100 can include structuresconfigured to mate with portions of the medical instrument 20 to beretained by the anchor device 100. For example, when the anchor deviceis in the closed configuration (as depicted in FIGS. 4A-4B), thegripping members 120 and 135 can define the channel 122 that extendslongitudinally from the proximal portion 103 of the anchor device 100toward the anchors 140 a and 140 b. The channel 122 can have one or morewalls configured to frictionally engage an outer surface of the catheter20 or other medical instrument to be anchored by the device 100. Forexample, during installation of the anchor device 100, the anchors 140 aand 140 b are directed toward the penetration point 32 through which thecatheter 20 passes. When the tines 145 a and 145 b are deployed in thesubcutaneous region 34, the cap assembly 130 can be removably coupled tothe base 110, which transitions the anchor device 100 to the closedconfiguration. As shown in FIGS. 4A-4B, openings 104 and 105 can bedefined by the base 110 and the cap assembly 130 when arranged in theclosed configuration. As such, the catheter 20 can extend though thechannel 122 when the anchors 140 a and 140 b are deployed under the skin30.

In some embodiments, the channel 122 can have one or more walls thatprovide a non-circular cross-sectional shape in a plane generallyorthogonal to the longitudinal axis of the channel 122. In theparticular embodiment shown in FIGS. 4A-4B, the openings 104 and 105 aregenerally diamond-shaped, and the channel 122 has a generallydiamond-shaped cross-section (e.g., including four walls). Such aconfiguration can conform to releasably engage an outer surface of thecatheter 20 in a manner that reduces the likelihood of overlycompressing the catheter 20 (which might otherwise hinder operation ofthe internal catheter lumens). Moreover, the channel 122 having thegenerally diamond-shaped cross-section can facilitate engagement with acatheter having a tapered outer surface (e.g., a larger outer diameteralong a proximal portion than the distal portion). The sizes of openings104 and 105 are defined by diagonals of lengths X and Y, respectively,as shown in FIGS. 4A-4B, respectively. In some embodiments, length Y islonger than length X, allowing for a better, more secure fit with acatheter 20 having a tapered shaped that decreases in diameter from theproximal portion to the distal portion. As such, in this particularembodiment, the channel 122 has a diamond-shaped cross-section and istapered so that it is generally wider at a proximal portion of thechannel than the distal portion of the channel 122. In otherembodiments, length X is longer than length Y, facilitating a catheterthat increases in diameter from the proximal end to the distal end.

In some embodiments, the anchor device 100 can be transitioned from theopen configuration (FIGS. 2-3) to the closed configuration (FIGS. 4A-4B)when the cap assembly 130 is coupled to the base 110. For example,during installation, the base 110 can be guided so that the anchors 140a and 140 b are directed through the penetration point 32 through whichthe catheter 20 passes. When the tines 145 a and 145 b are located inthe subcutaneous region 34 securing the anchor device 100 relative tothe skin 30 (see FIG. 1), the cap assembly 130 can be removably coupledto the base 110 to secure the catheter 20 relative to the anchor device100, thus securing the catheter 20 relative to the skin 30. In someembodiments, features of the anchor device 100 can removably couple thebase 110 to the cap assembly 130. In the example depicted in FIG. 3, thecap assembly 130 can be moved toward the base 110 (e.g., in thedirection depicted by arrow 106) to direct the tabs 112 toward to theopenings 132. When the diagonal faces of the tabs 112 contact theperimeters 134, the tabs 112 are stressed such that the tips 115 of thetabs 112 move closer to each other. When the face 135 moves beyond theengagement fingers 116, the tabs 112 can outwardly toward theirunstressed positions to releasably engage the perimeters 134. When inthis closed configuration, the cap assembly 130 and base 110 can apply acompressive force from the gripping members 120 and 135 to the catheter20 in the channel 122, thereby applying a frictional holding force tothe catheter 20 or medical instrument therein.

In some embodiments, the holding force that secures the catheter 20 tothe anchor device 100 can be released by separating the cap assembly 130from the base 110. The cap assembly 130 can be separated from the base110 by disengaging the locking tabs 112 from the cap assembly 130. Forexample, the base 110 can be separated from the cap assembly 130 byapplying pressure to the locking tabs 112 to move the tips 115 closer toeach other. When the engagement portions 116 of the tabs 112 move insidethe openings 132 in the cap 131, the retainer portions 120 and 135 forcethe cap assembly 130 away from the base 110 and the cap assembly 130becomes decoupled from the base 110, thus transitioning the anchordevice 100 to the open configuration (FIGS. 2-3). When the anchor deviceis in the open configuration, the catheter 20 can be moved relative tothe anchor device 100.

Optionally, at least a portion of the anchors 140 a and 140 b maycomprise a material that exhibits superelasticity when used in apatient's body. When the tines 145 a and 145 b of anchors 140 a and 140b are stressed by insertion through the skin penetration point 32, thetines 145 a and 145 b can superelastically flex from an expandedposition (see FIG. 2) to a partially contracted position. In thispartially contracted position, at least a portion of the tines 145 a and145 b may flex against the anchor shafts 141 a and 141 b. While againstthe anchor shafts 141 a and 141 b, the tines 145 a and 145 b can readilypenetrate through the skin penetration point 32 (which may be generallysmaller in width than the width occupied by the tines 145 a and 145 b ina fully expanded state). Such a feature can reduce the damage to thepatient's skin 30 during deployment of the anchors 140 a and 140 b.

In some embodiments, at least a portion of the anchors 140 a and 140 b(including the tines 145 a and 145 b) may be formed from a length ofnitinol wire or from a sheet of nitinol material, which has beenprocessed to exhibit superelasticity below or at about a normal humanbody temperature, such as below or at about 37 degrees C. The nitinolmaterial may comprise, for example, Nickel Titanium (NiTi), NiobiumTitanium (NbTi), or the like. Alternatively, the anchors 140 a and 140 bmay comprise a metal material such as stainless steel (e.g., 304stainless, 316 stainless, custom 465 stainless, and the like), springsteel, titanium, MP35N, and other cobalt alloys, or the like. Aspreviously described, the tines 145 a and 145 b of the anchors 140 a and140 b may extend substantially straight toward the free ends so that anincreased number of anchors per square area can be formed on each sheetof the selected metallic material. In another alternative, the anchors140 a and 140 b may be formed from a resilient polymer material. In someembodiments, the anchors 140 a and 140 b can be formed from a materialor materials that allow the tines 145 a and 145 b to be flexed to acontracted position and can resiliently return to an expanded position.

Referring now to FIGS. 6-7, the anchor device 100 can include featuresthat allow the individual anchors 140 a and 140 b to be moved relativeto each other so as to facilitate insertion and removal of the anchordevice 100 from the skin 30. In some embodiments, the anchor device 100comprises a foldable design in which a first portion of the base 110 ispivotably coupled to a second portion of the base 110. For example, theanchor device 100 can include a left portion 101 a and a right portion101 b (refer to FIGS. 6-7), which can be flexibly pivoted with respectto each other along a fold line 113 extending longitudinally through theretainer body 111. The left portion 101 a can include a left retainerbody portion 114 a fixedly coupled to the anchor 140 a, and the rightportion 101 b can include a right retainer body portion 114 b fixedlycoupled to the anchor 140 b. Thus, when the left and right retainer bodyportions 114 a and 114 b are pivoted about the fold line 113, the twoanchors 140 a and 140 b likewise pivot relative to one another. Thisprocess of folding the anchor device 100 can cause the anchor device 100to transition from a deployed configuration (shown in FIG. 2) where thetines 145 a and 145 b are oriented to extend in opposing directions to aremoval configuration (shown in FIG. 6) where the tines 145 a and 145 bare generally adjacent to each other and oriented to extend insubstantially the same direction. Folding the anchor device 100 intothis non-deployed configuration permits the anchors 140 a and 140 b tobe maneuvered in a manner that reduces the likelihood of the tines 145 aand 145 b causing damage to the skin 30 during insertion and removal.For example, as depicted in FIG. 6, the tines 145 a and 145 b can bearranged in a generally side-by-side position when the base 110 is inthe folded condition, thereby permitting the tines 145 a and 145 b to bereadily inserted (or removed) through the same skin penetration point 32that is occupied by the catheter 20.

As shown in FIG. 7, methods for using the anchor device 100 may includeadjusting the anchor device 100 to the non-folded condition after thesubcutaneous tines 145 a-b are inserted into the subcutaneous layer 34.As previously described, the free ends of the subcutaneous tines 145 a-bextend generally away from one another when the anchor device 100 isshifted to the non-folded condition. In such circumstances, thesubcutaneous tines 145 a-b are oriented in an anchored position in thesubcutaneous layer 34 so as to anchor the retention portion 111 relativeto the skin penetration point 32 that is occupied by the catheter 20.When in the anchored position, each of the tines 145 a-b can bemaintained at generally the same shape as when they were insertedthrough the skin penetration point (e.g., the generally non-stressedshape in which in which no other components of the anchor system 10 areforcing the tines 145 a-b to flex). Accordingly, the tines 145 a-b abutagainst the underside of the skin 30 and the rounded (non-sharp) tinetips 146 help to reduce the likelihood of puncturing the underside ofthe dermal layers 36 with the dull tips of the tines 146.

After the base 110 of the anchor device 100 is arranged in thenon-folded condition with the tines 145 a and 145 b abutting theunderside of the skin 30 near the skin penetration point, the catheter20 can be shifted into channel of the gripping member 120. As shown inFIG. 7, the catheter 20 can rest on the gripping member 120 of the base110 while the cap assembly 130 is connected to the base 110.Accordingly, the anchor device 100 releasably engage with the catheter20 at a location external to the skin penetration point 32 while theanchors 140 a and 140 b extend distally from the distal end the base 110to anchor to the skin penetration point 32 (using the subcutaneousanchor tines 145 a and 145 b). Such a configuration may allow the anchordevice 100 to be deployed after the catheter 20 is already in place(through the skin penetration point).

Still referring to FIGS. 6-7, the left and right retainer body portions114 a and 114 b can comprise a biocompatible polymer material (e.g.,PVC, polypropylene, polystyrene, or the like). In such embodiments, theretainer body 111 can be formed using a molding process in which theretainer body 111 is overmolded around a portion of the anchors 140 aand 140 b. Next, in a second molding process, an elastomer or othermaterial is molded into the retainer body 111 to create the retainerportion 120 that forms the bottom half of the channel 122. It should beunderstood from the description herein that the anchor 140 b can also becoupled to the retainer body 111 in a similar overmolding process. Itshould also be understood that there exist other manufacturing processesthat can secure the anchors 140 a and 140 b to the retainer body 111. Insome embodiments, the retainer body 111 and the anchors 140 a and 140 bcan be manufactured as a single piece. In some embodiments, the retainerbody 111 and retainer portion 120 can be manufactured as a single piece.

The left portion 101 a of the base 110 and the right portion 101 b ofthe base 110 can be formed as a single component that is bendable alongthe fold line 113. For example, the retainer body 111 can be configuredto resiliently maintain the shape depicted in FIG. 5. The base 110 canbe transitioned from the deployed configuration depicted in FIGS. 2-3 tothe insertion/removal configuration depicted in FIG. 6 (e.g., when theuser desires to insert or remove the anchor device 20 from a patient).At such time, the user may annually apply a bending moment to fold theanchor device 100 along the fold line 113, thus causing the anchordevice 100 to transition from the deployed configuration shown in FIGS.2-3 (where the tines 145 a and 145 b are substantially oriented inopposing directions) to the insertion/removal configuration shown inFIG. 6 (where the tines 145 a and 145 b are generally adjacent to eachother and oriented in substantially the same direction). In the depictedembodiment, the tines 145 a and 145 b can be rotated about 75-degrees toabout 105-degrees, and preferably about 90-degrees, during thetransition to the removal configuration.

Referring to FIG. 8, in one embodiment, the base 110 may include one ormore locating tabs 210 a, 210 b, 211 a, 211 b that serve to align andtemporarily retain a catheter 20 prior to engagement with the capassembly 130. The locating tabs 210 a, 210 b, 211 a, 211 b can hold thecatheter 20 in a selected axial alignment along the gripping member 120of the base 110 before cap assembly 130 (FIGS. 4A-B) mates with the base110 to provide a secure, frictional engagement along the outer surfaceof the catheter 20. Such an alignment feature provided by the locatingtabs 210 a-b or 211 a-b can be useful, for example, in circumstanceswhere the user is wearing surgical gloves that might reduce the abilityto handle the catheter 20 during the attachment of the cap assembly 130(FIGS. 4A-B). In some embodiments, only front locating tabs 210 a, 210 bare used, while in other embodiments, only back locating tabs 211 a, 211b are used. In a preferred embodiment, both front and back locating tabs210 a, 210 b, 211 a, 211 b are used. During manufacture, locating tabs210 a, 210 b, 211 a, 211 b may be integrally formed as a unitarystructure with the gripping member 120 of the base 110. In embodimentsthat include one or more locating tabs 210 a, 210 b, 211 a, 211 b, thegripping member 135 of the cap 130 can define opposing cavities toreceive the one or more locating tabs 210 a, 210 b, 211 a, 211 b in acomplementary manner during attachment of the cap assembly 130 to thebase 110.

Referring now to FIG. 9, some embodiments of the anchor device 100 mayinclude a cap alignment feature that serves to facilitate properalignment of the cap assembly 130 prior to attachment with the base 110.For example, in order to reduce the likelihood that a user might securethe cap assembly 130 onto the base 110 incorrectly the cap assembly 130may have non-symmetrical engagement features. In this embodiment, thecap assembly 130 includes a rib 216 on only one side, creating twoseparate openings 232 a and 232 b. The opposite side of the cap assembly130 can have a single opening 232 (rather than two openings separated bya rib). The base comprises three separate tabs 212, 212 a, 212 b. Thelarger tab 212 on one side of the base 110 is configured to fit withopening 232, while smaller tabs 212 a and 212 b on the other side of thebase 110 are configured to fit with openings 232 a and 232 b,respectively. As such, the cap 130 is configured to attach to the base110 in only one possible orientation when tab 212 is aligned withopening 232 and tabs 212 a and 212 b are aligned with openings 232 a and232 b. Given the location of the rib 216 and the asymmetric design ofthe cap 130 and base 110, the cap 130 cannot be secured to the base 110if the tabs 212, 212 a, 212 b and the openings 232, 232 a, 232 b are notproperly aligned.

Referring now to FIGS. 10-11, various embodiments of the anchor device100 may employ features to assist in the removal of the cap 130 from thebase 110. In this particular embodiment, a base tab 222 is used inconjunction with a cap tab 220 to facilitate removal of the cap 130 fromthe base 110. As shown in FIG. 10, the base tab 222 protrudes slightlyaway from cap tab 220 so a user can contemporaneously pinch or otherwisegrip both the base tab 222 and the cap tab 220 without interference. Inthis embodiment, at least one of the tabs 220 and 222 extends proximallyfrom a proximal end of the base 110. For example, the base tab 22 mayextend proximally rearward of the base 110 so that it is spaced apartfrom the cap assembly 130. In the example depicted in FIGS. 10-11, thebase tab 222 can be gripped by a user and forced (e.g., in the directiondepicted by arrow 224) in a direction that is generally opposite fromthe cap assembly 130 and the cap tab 222. Contemporaneously therewith,the cap tab 220 can be gripped and forced (e.g., in the directiondepicted by arrow 225) away from the base 110. In some embodiments, thebase 110 may be shaped to provide larger clearance to avoid interferencewith a user's fingertip when pulling up on the cap tab 220.

Referring to FIGS. 12-13, some embodiments of the anchor device 100 mayinclude cap removal features positioned on top of the anchor device 100so as to simplify removal of the cap assembly 130 from the base 110. Forexample, the tabs 112 on the base 110 may include cap removal features230 that extend upwardly above the cap assembly 130. In particular, whenthe cap 130 is secured to the base 110, the cap removal features 230protrude above the surface of the cap 130, thereby providing the userwith a surface to grip or engage for purposes of manually adjusting thetabs 112. As shown in FIG. 13, the user can manually engage and forcethe cap removal features 230 at a region above the cap assembly 130 andthereafter force the tabs 112 toward another. Such an action can causethe cap assembly 130 to readily release from the base 110 because thetabs 112 may disengaged from the cavities 112 of the cap assembly 130.Also, in some embodiments, the cap removal features 230 can be used topush the base 110 downward by pushing on the cap removal features 230while contemporaneously forcing the cap assembly 130 upward.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. An anchor device for securing the position of acatheter, comprising: means for releasably retaining a portion of acatheter external to a skin penetration point; and first and secondmeans for subcutaneously anchoring in a subcutaneous region to securesaid catheter retaining means relative to a skin penetration point,wherein the first and second anchoring means are fixedly mounted to saidcatheter retaining means and extend distally from a distalmost end ofsaid catheter retaining means, wherein said catheter retaining meansincludes a means for gripping an exterior surface of the catheter whensaid catheter retaining means releasably retains the portion of thecatheter, the gripping means extending generally parallel to alongitudinal axis of said catheter retaining means and having anon-circular cross-sectional shape in a plane generally perpendicular tothe longitudinal axis; wherein at least a portion of said catheterretaining means is foldable between a folded condition and a non-foldedcondition about a predefined fold axis extending generally parallel tothe longitudinal axis, and the first and second anchoring means arefixedly mounted to the foldable portion of said catheter retaining meansso that the first and second anchoring means move between the foldedcondition and the non-folded condition.
 2. The anchor device of claim 1,wherein said catheter retaining means comprises a base and a cap thatreleasably couples with the base so as to define the gripping meanstherebetween.
 3. The anchor device of claim 2, wherein the grippingmeans comprises a compliant gripper member positioned on each of thebase and the cap so as to frictionally engage the catheter with thegripping means when said catheter retaining means releasably retains theportion of the catheter.
 4. The anchor device of claim 2, wherein thebase further comprises one or more means for aligning the catheteradjacent to the base prior to engagement of the base with a cap.
 5. Theanchor device of claim 2, wherein the base comprises non-symmetricalengagement features and the cap comprises non-symmetrical engagementfeatures such that the cap is configured to attach to the base in onlyone orientation.
 6. The anchor device of claim 1, wherein the grippingmeans is at least partially defined by a wall comprising a thermoplasticelastomer material to press against the catheter when said catheterretaining means releasably retains the portion of the catheter.
 7. Theanchor device of claim 1, wherein the first and second anchoring meansextend distally from the distalmost end of said catheter retaining meansto deploy into the skin penetration point occupied by the catheter whensaid catheter retaining means releasably retains the portion of thecatheter.
 8. The anchor device of claim 1, wherein the non-circularcross-sectional shape of the gripping means comprises a four-sidedshape.
 9. The anchor device of claim 1, wherein the gripping meanscomprises a channel having a proximal opening and a distal opening, theproximal opening of the channel being larger than the distal opening ofthe channel.
 10. The anchor device of claim 9, wherein at least aportion of the channel is tapered to provide a larger size at a proximalregion of the channel.
 11. The anchor device of claim 1, wherein thefirst and second anchoring means comprise first and second flexibletines, respectively, which extend substantially straight to respectivefree ends having rounded tine tips.
 12. An anchor device for securingthe position of a catheter, comprising: means for releasably retaining aportion of a catheter external to a skin penetration point; and firstand second means for subcutaneously anchoring in a subcutaneous regionto secure said catheter retaining means relative to a skin penetrationpoint, wherein the first and second anchoring means are fixedly mountedto said catheter retaining means and extend distally from a distalmostend of said catheter retaining means, wherein said catheter retainingmeans includes a means for gripping an exterior surface of the catheterwhen said catheter retaining means releasably retains the portion of thecatheter, the gripping means extending generally parallel to alongitudinal axis of said catheter retaining means and having anon-circular cross-sectional shape in a plane generally perpendicular tothe longitudinal axis; wherein at least a portion of said catheterretaining means is foldable about a predefined fold axis extendinggenerally parallel to the longitudinal axis, and wherein the first andsecond anchoring means comprise first and second flexible tines,respectively, which are arranged in a generally side-by-side positionwhen said portion of said catheter retaining means is in a foldedcondition, and wherein the flexible tines of the first and secondanchoring means extend generally away from one another when said portionof said catheter retaining means is in a non-folded condition.
 13. Theanchor device of claim 12, wherein the first and second anchoring meansextend distally from the distalmost end of said catheter retaining meansto deploy into the skin penetration point occupied by the catheter whensaid catheter retaining means releasably retains the portion of thecatheter.
 14. An anchor device for securing the position of a catheter,comprising: means for releasably retaining a portion of a catheterexternal to a skin penetration point; and first and second means forsubcutaneously anchoring in a subcutaneous region to secure saidcatheter retaining means relative to a skin penetration point, whereinthe first and second anchoring means are fixedly mounted to saidcatheter retaining means and extend distally from a distalmost end ofsaid catheter retaining means, wherein a distal portion of each of thefirst and second anchoring means comprises a flexible tine that isdeployable in the subcutaneous region and that extends substantiallystraight to a respective free end having a rounded tine tip; whereinsaid catheter retaining means includes a means for gripping an exteriorsurface of the catheter when said catheter retaining means releasablyretains the portion of the catheter, the gripping means extendinggenerally parallel to a longitudinal axis of said catheter retainingmeans; and wherein at least a portion of said catheter retaining meansis foldable between a folded condition and a non-folded condition abouta predefined fold axis extending generally parallel to the longitudinalaxis, and the first and second anchoring means are fixedly mounted tothe foldable portion of said catheter retaining means so that the firstand second anchoring means move between the folded condition and thenon-folded condition.
 15. The anchor device of claim 14, wherein saidcatheter retaining means comprises a base and a cap that releasablycouples with the base so as to define the gripping means therebetween.16. The anchor device of claim 15, wherein the gripping means comprisesa compliant gripper member positioned on each of the base and the cap soas to frictionally engage the catheter with the gripping means when saidcatheter retaining means releasably retains the portion of the catheter.17. The anchor device of claim 15, wherein the base comprisesnon-symmetrical engagement features and the cap comprisesnon-symmetrical engagement features such that the cap is configured toattach to the base in only one orientation.
 18. The anchor device ofclaim 14, wherein the flexible tines of the first and second anchoringmeans are pivoted about 75-degrees to about 105-degrees when the firstand second anchoring means are adjusted from a deployed configuration toa removal configuration.
 19. The anchor device of claim 14, wherein thefirst and second anchoring means extend distally from the distalmost endof said catheter retaining means to deploy into the skin penetrationpoint occupied by the catheter when said catheter retaining meansreleasably retains the portion of the catheter.
 20. The anchor device ofclaim 14, wherein the gripping means comprises a channel having anon-circular, four-sided cross-sectional shape in a plane generallyperpendicular to the longitudinal axis.